Byetta (Exenatide Injection) - Summary

BYETTA SUMMARY

BYETTA^® (exenatide) is a synthetic peptide that has incretin-mimetic actions and was originally identified in the lizard Heloderma suspectum. BYETTA enhances glucose-dependent insulin secretion by the pancreatic beta-cell, suppresses inappropriately elevated glucagon secretion, and slows gastric emptying. Exenatide differs in chemical structure and pharmacological action from insulin, sulfonylureas (including D-phenylalanine derivatives and meglitinides), biguanides, thiazolidinediones, and alpha-glucosidase inhibitors. Exenatide is a 39−amino acid peptide amide.

BYETTA is indicated as adjunctive therapy to improve glycemic control in patients with type 2 diabetes mellitus who are taking metformin, a sulfonylurea, a thiazolidinedione, a combination of metformin and a sulfonylurea, or a combination of metformin and a thiazolidinedione, but have not achieved adequate glycemic control.

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NEWS HIGHLIGHTS

Published Studies Related to Byetta (Exenatide Injection)

Effects of HbA1c and weight reduction on blood pressure in patients with type 2 diabetes mellitus treated with exenatide*. [2012]
with either exenatide twice daily (BID) or once weekly (QW)... CONCLUSION: Although the mechanism of BP-lowering effect of exenatide is not

Investigation of the haemodynamic effects of exenatide in healthy male subjects. [2012]
male volunteers... CONCLUSIONS: Exenatide has significant haemodynamic effects in healthy

Exenatide as a Weight-Loss Therapy in Extreme Pediatric Obesity: A Randomized, Controlled Pilot Study. [2011.11.10]
The objective of this pilot study was to evaluate the effects of exenatide on BMI (primary endpoint) and cardiometabolic risk factors in nondiabetic youth with extreme obesity. Twelve children and adolescents (age 9-16 years old) with extreme obesity (BMI >/=1.2 times the 95th percentile or BMI >/=35 kg/m(2)) were enrolled in a 6-month, randomized, open-label, crossover, clinical trial consisting of two, 3-month phases: (i) a control phase of lifestyle modification and (ii) a drug phase of lifestyle modification plus exenatide...

Exenatide or glimepiride added to metformin on metabolic control and on insulin resistance in type 2 diabetic patients. [2011.09]
The aim of this study was to evaluate the effect of exenatide compared to glimepiride on body weight, glycemic control and insulin resistance in type 2 diabetic patients taking metformin. One hundred and eleven patients with uncontrolled type 2 diabetes mellitus and intolerant to metformin at the highest dosages (2500-3000 mg/day) were enrolled in this study...

[Cost-effectiveness of exenatide versus insulin glargine in Spanish patients with obesity and type 2 diabetes mellitus]. [2011.08]
BACKGROUND AND OBJECTIVES: Exenatide, a GLP-1 receptor agonist for adjuvant treatment of type 2 diabetes mellitus (T2DM), has been shown to be as effective as insulin glargine (IG) for reducing glycated hemoglobin levels combined with metformin or/and sulphonylureas. Exenatide is associated to weight reduction and a higher incidence of gastrointestinal adverse events. The objective of this study was to assess the cost-effectiveness of exenatide as compared to IG in obese patients with T2DM not achieving an adequate blood glucose control from the perspective of the Spanish healthcare system... CONCLUSIONS: Exenatide was associated to greater clinical benefits and higher costs in obese T2DM patients as compared to IG. Considering a willingness-to-pay threshold of euro 30,000 per QALY gained in the Spanish setting, exenatide represents an efficient option in comparison with IG. Copyright (c) 2010 SEEN. Published by Elsevier Espana. All rights reserved.

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Clinical Trials Related to Byetta (Exenatide Injection)

Effects of Exenatide Long-Acting Release on Glucose Control and Safety in Subjects With Type 2 Diabetes Mellitus(DURATION - 1) [Active, not recruiting]
The purpose of this study is to examine the effects of exenatide long-acting release (LAR) on glucose control and safety in subjects with type 2 diabetes mellitus managed with diet modification and exercise and/or oral antidiabetic medications.

An Exploratory Study of the Effect of Treatment Interruption on Safety of Exenatide in Patients With Type 2 Diabetes [Completed]
The primary purpose of this study is to assess the anti-exenatide-antibody response to exenatide re-exposure as measured by anti-exenatide antibodies and incidence of treatment-emergent allergy and hypersensitivity reactions following a period of treatment interruption, in patients previously exposed to exenatide.

Efficacy and Safety of Exenatide in Japanese Patients With Type 2 Diabetes Who Are Treated With Oral Antidiabetic(s) [Active, not recruiting]
This long term, placebo-controlled trial is intended to assess the efficacy and safety of exenatide, dosed twice a day, in Japanese patients with Type 2 Diabetes who are treated with oral antidiabetic(s) but not well controlled.

A Study by Scintigraphy to Evaluate the Effect of Exenatide on Gastric Emptying in Subjects With Type 2 Diabetes [Completed]
As exenatide slows the rate at which materials leave the stomach, it is likely to alter the rate of intestinal absorption of oral drugs when administered within a certain timeframe relative to exenatide. In addition, the residence time within the stomach of other medication may be prolonged and data from this study will help assess the change in residence time in the presence of therapeutic doses of exenatide. This study will also evaluate the relationship between blood levels of exenatide and parameters measuring rate of stomach emptying.

Safety and Efficacy of Exenatide as Monotherapy [Completed]
This Phase 3 trial is designed to compare the effects of twice-daily exenatide and twice-daily placebo with respect to glycemic control in drug-naive patients with type 2 diabetes treated with diet and exercise.

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Reports of Suspected Byetta (Exenatide Injection) Side Effects

Pancreatitis (282),  Weight Decreased (157),  Nausea (152),  OFF Label USE (138),  Pancreatitis Acute (112),  Blood Glucose Increased (109),  Renal Failure (106),  Vomiting (100),  Pancreatic Carcinoma (96),  Diarrhoea (49), more >>

PATIENT REVIEWS / RATINGS / COMMENTS

Byetta review by 42 year old female patient
		Rating
Overall rating:
Effectiveness:		Highly Effective
Side effects:		Mild Side Effects
		Treatment Info
Condition / reason:		diabetes
Dosage & duration:		10mcg (dosage frequency: 2x daily) for the period of 2 years
Other conditions:		narcolepsy
Other drugs taken:		provigil
		Reported Results
Benefits:		helped to stay awake, without the side effects that I had when I used to take dexedrine, like jittery, agitation, dry mouth
Side effects:		There really weren't any side effects like those described above from dexedrine.
Comments:		100-150 mg a day, 100mg taken in the am, 50mg in pm (if needed) to help with daytime sleepiness, caused by narcolepsy. I usually do not take the afternoon dose unless I feel really tired and nervous about driving.

Byetta review by 51 year old female patient
		Rating
Overall rating:
Effectiveness:		Highly Effective
Side effects:		Mild Side Effects
		Treatment Info
Condition / reason:		Diabetic
Dosage & duration:		10 mcg (dosage frequency: twice daily) for the period of 4 years
Other conditions:		blockage & allergies
Other drugs taken:		metformin, allegra, lipator, tricor
		Reported Results
Benefits:		This slows the sugar going into my system so that my body can use most of my own insulin to process the sugar. It is to be taken along with the metformin. It has helped control my blood sugar very well.
Side effects:		It can sometimes cause nausea. At the start of treatment it was bad but now it only happens if I miss a dose then the next one will cause nausea. The first couple of months I saw a very slight drop in weight but I am not sure if the Byetta caused this.
Comments:		I take a shot before my first meal and last meal each day. It is a very easy shot to give to myself but it is easy to forget if I eat out or if I am traveling.

Byetta review by 56 year old female patient
		Rating
Overall rating:
Effectiveness:		Marginally Effective
Side effects:		Severe Side Effects
		Treatment Info
Condition / reason:		obesity and diabetes
Dosage & duration:		5mcg and 10mcg (dosage frequency: 2 times per day) for the period of 2 years
Other conditions:		none
Other drugs taken:		luvox, norvasc, metformin
		Reported Results
Benefits:		I initially had severe cramping and nausea, but I continued under doctor's orders, I only lost about 20 pounds, tops. I now have a larger host of problems I believe were started with this medication. I have not used in 3 years.
Side effects:		Severe cramping, headaches, incredible nausea, muscle cramps, vomiting blood (not once but on 2 occasions due to doctor's orders). I now am facing something wrong with my digestive tract and no doctor has been able to figure out what is wrong. Since this is the area where the medication was injected, and only there, I believe that the byetta is the perfect suspect. Now, if I could only find a doctor that will listen to me. The count is 5 and still increasing. Recently, I lost 4 pounds in 3 days!!!! This is not normal!
Comments:		I was to inject the said amount into the abdominal (below the waist, above the pelvic bone) before breakfast and lunch. The amount was changed when the medical professional I was having treat me decided to increase the dosage, and with terrible results (I was vomiting blood and could not eat or even drink water - I couldn't even stand the smell of food). I wish I had never heard of Byetta!!!!!!